Services

  • Strategic Planning
  • Design nonclinical drug development programs for a variety of drug classes.
  • Provide support for all phases of nonclinical drug development activities including toxicology, pharmacokinetics, ADME, and safety pharmacology programs.
  • Establish and manage all interactions with contract research organizations (CROs) including:
    • Proposal generation
    • CRO selection
    • Auditing
    • Contract set-up
    • Study design
    • Study monitoring
    • Report review
  • Prepare nonclinical sections of:
    • INDs, NDAs, etc., in Common Technical Document (CTD) format for regulatory filings (e.g., FDA, EMA, Health Canada).
    • Investigator’s Brochures
  • Interact with regulatory agencies.
  • Qualify impurities in drug substances and drug products.
  • Provide assistance with government contracts (experience as PI).
  • Provide product liability/forensic toxicology support.Having a big sale, on-site celebrity, or other event? Be sure to announce it so everybody knows and gets excited about it.

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Click Below for Levine Tox Consulting Brochure